Nerandomilast in idiopathic pulmonary fibrosis: data from the whole follow-up period of the FIBRONEER-IPF trial
Year: 2026
Type: article
Abstract: RATIONALE: In the randomized placebo-controlled FIBRONEER-IPF trial in patients with idiopathic pulmonary fibrosis, both nerandomilast 9 mg bid and 18 mg bid met the primary endpoint of reducing decline in forced vital capacity at week 52. Patients continued to receive randomized treatment after week 52, until the last patient had completed an end-of-treatment visit. OBJECTIVES: To assess the effects of nerandomilast over the full duration of follow-up in the FIBRONEER-IPF trial. METHODS: Time to first acute exacerbation of IPF, hospitalization for respiratory cause, or death (key secondary endpoint) and other time-to-event endpoints were assessed at final database lock. MEASUREMENTS AND MAIN RESULTS: 1177 patients were treated. Mean (SD) exposure to trial medication was 14.8 (5.0), 14.9 (5.0) and 14.7 (5.3) months in the placebo, nerandomilast 9 mg bid and nerandomilast 18 mg bid groups, respectively. Compared with placebo, the hazard ratio (95% CI) for the key secondary endpoint was 0.92 (0.69, 1.22) for nerandomilast 9 mg bid and 0.99 (0.75, 1.31) for nerandomilast 18 mg bid and the hazard ratio (95% CI) for death was 0.95 (0.61, 1.49) for nerandomilast 9 mg bid and 0.66 (0.41, 1.08) for nerandomilast 18 mg bid. Adverse events led to treatment discontinuation in 13.0%, 13.5% and 16.1% of the placebo, nerandomilast 9 mg bid and nerandomilast 18 mg bid groups, respectively. CONCLUSIONS: In the FIBRONEER-IPF trial, nerandomilast had no effect on the composite endpoint of time to first acute exacerbation of IPF, hospitalization for respiratory cause, or death, but nerandomilast 18 mg bid was associated with a numerically lower risk of death. Nerandomilast had a favorable safety profile, with a low rate of discontinuation due to adverse events.
Authors: Justin M Oldham, Arata Azuma, Michael Kreuter, Toby M Maher, Fernando J Martinez, Luca Richeldi, Claudia Valenzuela, Marlies S Wijsenbeek, Yi Liu, Diane Zisa, Donald F Zoz, Vincent Cottin, FIBRONEER-IPF trial investigators, P C Elias, G P De Stefano, A Casey, M J Fernandez, L A Wehbe, H M Castro, M Otaola, I Glaspole, N Goh, J Wrobel, T Corte, J Wheatley, D Chambers, G Keir, S Schembri, J Mackintosh, S Bowler, P Bremner, I Glaspole, C Lambers, S Handzhiev, M Steinmaurer, A Valipour, M Rauter, M Studnicka, G Brusselle, W Wuyts, A Froidure, B Bondue, C Dahlqvist, J Guiot, H Slabbynck, A S Rubin, M F Rabahi, G Zonzin, K M Storrer, E Mancuzo, A L Francisco Pez, F E Arimura, P Hernandez, C Ryerson, M Kalluri, J D Rolf, G Cox, S Anees, G Dion, M Mallet, H Manganas, E Millaire, D Assayag, D Marinescu, R S Silva Orellana, M R Salinas Fénero, Z Xu, J Cao, H Peng, Q Luo, J Xu, M Cao, F Li, H Zhu, T Bian, H Dai, F Wen, H Zhang, W Ma, W Huang, L Wang, Y Meng, K Hu, L Gao, X Li, X Xu, Q Hong, S Yang, G Shi, B Chen, T Zhao, W Li, Y Fu, Q Zhang, E Chen, X Wang, J Huang, L Rong, D Zhu, D Ljubicic, E Bendstrup, S B Shaker, I Titlestad, M Jaanus, M Myllärniemi, R Kaarteenaho, M Salaun, G Prévot, E Bergot, J Cadranel, S Jouneau, S Hirschi, L Stervinou-Wemeau, F Lebargy, B Crestani, V Cottin, M Reynaud-Gaubert, F Gagnadoux, S Quetant, S Marchand-Adam, J Naccache, H Nunes, S Dirou, D Montani, A Chabrol, S Leroy, P Bonniaud, E Blanchard, F Couturaud, D Koschel, A Kirsten, J Kirschner, S Walterspacher, H Kabitz, J Behr, F Herth, M Kreuter, P Hammerl, F Bonella, J Ficker, W Spengler, S Stieglitz, T Oqueka, L Hagmeyer, M Westhoff, T Fühner, C Warnke, S Gläser, D Skowasch, C Neurohr, S Gregor, A Prasse, K Antoniou, A Tzouvelekis, K Kostikas, R Gajdocsi, A Sarkozi, E Judge, L Richeldi, E Balestro, E Bargagli, M Bonifazi, S Cerri, S Harari, D Lacedonia, C Ravaglia, P Rogliani, S Tomassetti, C Vancheri, Y Kondoh, M Bando, K Tomii, S Izumi, K Tobino, H Tomioka, T Kawamura, N Sakamoto, H Ishii, H Kitamura, M Okamoto, T Suda, T Arai, Y Inoue, O Nishiyama, K Imaizumi, M Kato, K Ichikado, K Kuronuma, S Sato, T Suzuki, K Kishi, Y Waseda, K Sugino, H Akamatsu, D Fujimoto, I Okamoto, H Matsushima, N Ishikawa, T Isobe, S Abe, Y Tanino, Y Zaizen, M Tamaoka, S Sakao, N Muhammad, S Sirol Aflah, L Pereirasamy, S Kho, U Chavarria Martinez, R Barriga Acevedo, E A Reyes Garcia, F Solorzano Trelles, A Ramirez Venegas, A A Colli Dominguez, R L Mostard, M Wijsenbeek-Lourens, M Veltkamp, C Chang, M Wilsher, C O’Dochartaigh, S Poole, T L Eagan, R Gagama, M Durheim, A Sieminska, W Tomkowski, B Mackiewicz, T Alfaro, I Neves, M Chung, H Yoon, J S Park, J Park, Y H Kim, M S Park, Y Choi, J W Song, S Y Low, G T Chai, V Lim, H J van Rensburg, I Abdullah, U Lalloo, M Arias, I Ojanguren, M Molina-Molina, J Sellares, M Aburto, M V Leal Arranz, B Salinas, E Cano Jiménez, J Suárez Antelo, C Valenzuela, J M Echave Sustaeta, J Rigual, R García Sevila, E Fernández Fabrellas, E Balcells, R Pérez Rojo, S Eizaguirre, J Cifrián, Z Palacios, J De Miguel Díaz, J A Rodríguez Portal, J L Velasco, J Sauleda, B López Muñiz, J A Ros, A D Romero Ortiz, O Emilsson, M Kokkala, O Emilsson, E Ekbom, K Hostettler Haack, H Wang, D Perng, S Cheng, P Fu, C Lin, K Huang, C Sheu, T Huang, S Disayabutr, P Ratanawatkul, T Petnak, A Limsukon, K Bangpattanasiri, A Navasakulpong, P Molyneaux, N Hirani, H Adamali, P Beirne, M Gibbons, R Hoyles, P Rivera-Ortega, T Gatheral, M B Scholand, M J Hamblin, S K Bellam, A P Milstone, N R Warshoff, C T Harden, D C Patel, R A Abrencillo, L H Lancaster, A Hajari Case, H J Kim, D E Phillips, J A Lasky, P P LaCamera, T M Maher, C McGroder, D Zhang, T Kulkarni, F J Averill, T D Kaelin, T Moua, D L Hotchkin, T D Russell, G M Hunninghake, S S Weigt, F O Alabi, R J Fowler, L D Morrison, T Zaman, S J Halliday, J Roman, M E Kreider, N Sandorfi, R J Kaner, N Gupta, L E Morrow, D M Hershberger, R K Dixon, C J Mello, T E Albertson, A M Nambiar, B A Mina, N A Ettinger, S Kable, B S Shea, F Kassamali Madhani-Lovely, H D Haller, C M Fleury, D E Antin-Ozerkis, A U Aranda-Rodriguez, R I Enelow, B E Disilvio, T J Cheema, J J Swigris, J J Solomon, A J Gerbino, N Y Bhatt, J S V Sheth, K R Flaherty, G B Nair, G J Criner, M G Kaye, L B Tolle
Institutions: University of Michigan, Nippon Medical School, University Medical Center of the Johannes Gutenberg University Mainz, University of Southern California, Imperial College London, University of Massachusetts Chan Medical School, Università Cattolica del Sacro Cuore, Agostino Gemelli University Polyclinic, Istituti di Ricovero e Cura a Carattere Scientifico, Hospital Universitario de La Princesa, Universidad Autónoma de Madrid, Erasmus MC, Boehringer Ingelheim (United States), Lyon 1 Université, Hospices Civils de Lyon, Hôpital Louis Pradel
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Funder: Boehringer Ingelheim
OpenAlex ID: W7130829221